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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Gastro-Enterostomy
510(k) Number K170323
Device Name Entuit Start Initial Placement Gastrostomy Set
Applicant
Cook Incorporated
450 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Erum B. Nasir
Correspondent
Cook Incorporated
450 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Erum B. Nasir
Regulation Number876.5980
Classification Product Code
KGC  
Date Received02/01/2017
Decision Date 09/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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